drugset / Trial / NCT00482092
Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.
Timeline
- Start
- 2007-09-17
- Primary completion
- 2014-09-15
- Completion
- 2014-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prochymal® | Cell therapy | 600 cells | Intravenous |
| Comparator | Prochymal® | Cell therapy | 1200 cells | Intravenous |